Nurses moving into clinical trial jobs must change mindset about patients

Experts say the different missions can be confusing

One ethical dilemma nurses face when they move from clinical care to clinical research is the way the two fields' missions are different with regard to patients.

In fact, many argue that clinical research participants should not be called "patients," even when they are visiting a hospital or clinic partly for patient care and partly for their research visit.

The problem is training nurses to view these people differently.

"This is a very serious problem and nothing is being written about it," says Carlton A. Hornung, PhD, MPH, a professor of medicine in the department of epidemiology and population health and the director of the Office of Education and Career Development in the Clinical and Translational Science Institute of the University of Louisville.

"Certificate nursing schools and baccalaureate nursing schools really do not train nurses in what are the ethics for clinical trials," Hornung says.

Since a majority of clinical trial subjects now are enrolled at non-academic medical sites, such as private doctors' offices and outpatient medical clinics, this issue has to be more of a priority, Hornung notes.

While academic medical centers could provide training to groups of nurses and CR staff, small clinical trial sites have to handle this on a more individual basis.

But anecdotal evidence suggests CR sites are not doing an adequate job of providing ethical training to their nursing staffs, Hornung says.

"One study I saw from a student obtaining her master's degree at the University of Louisville found that 70% of nurses do not believe a patient in a clinical trial is getting the best care," Hornung explains.

Opposing philosophies

This contradiction could be explained by the different philosophical attitudes nurses have versus trained CR professionals.

"Nurses are trained that their first obligation is to the patient and what they see as the patient's best interest," says Mark Rothstein, JD, director of the Bioethics Institute at the University of Louisville School of Medicine in Louisville, KY.

"But nurses also have an ethical responsibility to respect the self-determination of their patients," Rothstein adds. "And if a patient provides informed consent to participate in a clinical trial, then the nurse should not deviate from the protocol on the grounds that he or she thinks it's not the standard therapy or that it's an undue burden on the nurse."

It's the researchers' responsibility to make sure the clinical trial staff is well-educated about what they need to do and why it's important, says Pamela Normandin, RN, MSN, CCRC, a clinical nurse specialist in the office of research at Iowa Lutheran Hospital in Des Moines, IA.

"It takes time up front training nurses, and I know a lot of research groups don't do it," Normandin says.

"I work in a hospital where there are many research groups," she adds. "And some do a really good job, and some do not."

The key is the upfront training because that is what could make or break a trial, Normandin says.

The consequence of not teaching nurses about research ethics is that it's difficult for some nurses to fully grasp the importance of clinical research equipoise, Hornung says.

Research subjects often are randomized to a new drug or treatment or to standard care or a placebo, and no one on the research team knows which patient receives which treatment. Also, no one knows for certain which will be better for the patient until the data are collected, Hornung explains.

"Nurses are committed to providing the best possible care to their patients, and they're not always in agreement that the clinical trial protocol is the best possible care for a patient who is randomized to one arm or another," Hornung says. "And when those nurses do not adhere to the protocol and provide instead what they think is the best care, you end up with lost data, and the research subject's rights are violated."

This problem often is subtle.

For example, a nurse may delay obtaining a CR blood draw because the time for which it's scheduled is inconvenient for the research subject. Or maybe the nurse also has other clinical staffing duties and another patient needs emergency attention at 4 p.m. when the blood draw is scheduled, and so she's delayed by two hours in getting to the research participant.

"That might render whatever readings you get from the blood draw invalid," Hornung says.

"On one hand this is an ethical dilemma for nurses under certain conditions, especially in acute care situations," he adds. "And it's a problem for floor nurses given the incredible demands put on them with the number of patients they have to handle."

Full training critical

The solution is to make certain all nurses who move into clinical trial work are fully trained.

"What I want to do is make sure that nurses working in academic medical centers where there are numerous clinical trials going on are aware of the atmosphere in which they're working," Rothstein says.

"Many of their patients are involved in clinical trials, and they need to know what the consequences of that are and what are the ethical duties of nurses who work in clinical research," Rothstein says.

The only time nurses should question a clinical trial is if there's an unanticipated adverse event to a drug or if the nurse believes there is something unethical about the trial itself, Rothstein notes.

The solution is for academic institutions and individual research sites to provide specific ethical training to their nursing staff, focusing on how clinical trial care differs from clinical care, Rothstein and Hornung say.

"In addition, institutions need to provide back-up support for nurses," Rothstein says.

For example, in the scenario of a nurse who misses a scheduled clinical trial blood draw because of having to handle a patient in crisis down the hall, it's the research site's fault for not providing that nurse with back-up support, Rothstein explains. "Institutions need to have quick, easy access to the research coordinator or investigators if there are questions or emergencies," he adds.